Screening of Pulmonary Hypertension in Methamphetamine Abusers

NCT04019600 | Suspended

• 1 other identifier: SOPHMA study protocol_v.1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Methamphetamine is misuse if classified as a "likely" risk factor for pulmonary arterial hypertension (PAH). Nevertheless the actual prevalence of and a screening strategy for PAH in methamphetamine users have not been established. In this study, the prevalence of PAH will be investigated and its independent risk factors among methamphetamine users will be identified.

Conditions

Methamphetamine Abuse; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Diagnosis of PAH in methamphetamine users

  Diagnosis and subtypes, as well as prevalence of PAH in methamphetamine users

  3 years

Secondary Outcomes (1)

• Risk factors of PAH in methamphetamine users

  3 years

Interventions

Echocardiography OTHER

Demographic data and health risk factors will be collected on day of screening, together with the above tests. Right heart catheterization will be separately arranged in patients with a high echocardiographic probability of PAH. For those with a low-intermediate echocardiographic probability, screening will be repeated within 1 year to ensure true negativity of the original scan.

Also known as: 12-lead electrocardiogram, Serum sampling for brain natriuretic peptide and other biomarkers, 6-minute walking test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with a history of methamphetamine use followed-up in the participating substance abuse clinic will be identified via the computerized database of the clinical management system.

You may qualify if:

• \>= 18 years at enrollment
• report of methamphetamine use in the last 2 years
• diagnosed as amphetamine dependent according to the Diagnostic and Statistical Manual of Mental Disorders (the 5th edition) (DSM-V)(13)
• voluntarily agree to participate by providing written informed consent

You may not qualify if:

• failed or refused to provide written informed consent
• Reference:
• \. Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas 2013;25(2):191-2.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Siu-Han JoJo Hai, MBBS

  Cardiac Division, the University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 15, 2019
• Study Start: December 23, 2019
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: August 10, 2021

Record last verified: 2021-08

Locations

HK (1)